Recently, the FDA granted approval to cemiplimab (Libtayo®, Regeneron Pharmaceuticals) for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) who were previously treated with a hedgehog pathway inhibitor (HHI) or who are ineligible for HHI therapy. In this interview, Karl Lewis, MD, Professor of Medical Oncology at the University of Colorado Anschutz Medical Campus and one of the investigators of Study 1620 (NCT03132636), on which the approval was based, speaks with Oncology Data Advisor about the challenges of treating patients with locally advanced or metastatic BCC and the significance of the cemiplimab approval for this disease.
What are some of the most challenging aspects of treating patients with locally advanced or metastatic BCC?
Karl Lewis, MD: Locally advanced or metastatic BCC is a very difficult disease to treat and is often a disfiguring tumor that can significantly impact quality of life in a negative way. Traditionally, we haven't had effective medications for these tumors. There are two approved HHIs, vismodegib and sonidegib, that can produce significant responses, but not everybody responds to these agents. They can also be associated with a fair amount of toxicity and therefore can be hard to use for extended periods of time. Beyond those, there really were no medical options for these patients until the approval of cemiplimab.
What is the significance of the approval of cemiplimab for patients with locally advanced or metastatic BCC?
Dr. Lewis: The approval of cemiplimab provides us with a medication that has shown to be highly effective for patients with BCC. It also has an advantage as an immunotherapy in that if we can get the immune system to target the tumor, then that gives the patient a chance at experiencing a durable benefit in terms of controlling their cancer.
Are there any particular adverse events that should be monitored for in patients receiving cemiplimab?
Dr. Lewis: There are specific adverse events that require close monitoring, but overall, the safety profile of cemiplimab is very consistent with that of other medications in its class. As a programmed cell death protein 1 (PD-1) antibody, cemiplimab is associated with the development of autoimmune toxicities, including colitis, hepatitis, pneumonitis, and endocrine abnormalities. Patients need to be monitored just as they would for any of the other checkpoint inhibitor immunotherapies.
What are some of the questions that you commonly encounter from patients with locally advanced or metastatic BCC, and how do you counsel them?
Dr. Lewis: The first question is whether the disease is surgically resectable. If patients aren't candidates for surgery, the next question is whether the disease is amenable to local radiation therapy. For those with locally advanced or metastatic BCC who require systemic therapy, patients want to know what their therapeutic options are. Up until this point, HHIs were our only option, but with the approval of cemiplimab, we now have another option for locally advanced or metastatic BCC.
About Dr. Lewis
Karl Lewis, MD, is a Professor of Medical Oncology at the University of Colorado Anschutz Medical Campus in Denver, Colorado. He specializes in the treatment of patients with skin cancer, including malignant melanoma and BCC. Dr. Lewis is a member of the American Society of Clinical Oncology, the Society for Melanoma Research, and the Southwest Oncology Group. He serves as principal investigator or co-investigator of several clinical trials focusing on the development of novel therapeutics for patients with melanoma, and he has authored or coauthored numerous publications in peer-reviewed journals.
For More Information
Lewis K, Peris K, Sekulic A, et al (2020). Interim analysis of phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma (mBCC) who progressed on or are intolerant to hedgehog inhibitors (HHIs). J Immunother Cancer (Society for Immunotherapy of Cancer Annual Meeting Abstracts), 8(suppl_3). Abstract 428. DOI:10.1136/jitc-2020-SITC2020.0428
Stratigos AJ, Sekulic A, Peris K, et al (2020). Primary analysis of phase II results for cemiplimab in patients (pts) with locally advanced basal cell carcinoma (laBCC) who progress on or are intolerant to hedgehog inhibitors (HHIs). Ann Oncol (ESMO Virtual Congress Abstracts), 31(suppl_4):S1142-S1215. Abstract LBA47. DOI:10.1016/annonc/annonc325
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.